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An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obliged to report complaints. [ 5 ] In June 2015, the FDA reported an investigation into Essure and its over 5000 complaints, seven reported deaths, and many additional side effects, all linked to Essure, its specific chemical ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
Total hip replacement is most commonly used to treat joint failure caused by osteoarthritis.Other indications include rheumatoid arthritis, avascular necrosis, traumatic arthritis, protrusio acetabuli, [5] certain hip fractures, benign and malignant bone tumors, [6] arthritis associated with Paget's disease, [7] ankylosing spondylitis [8] and juvenile rheumatoid arthritis. [9]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010.
The consumer healthcare company is recalling the cough syrup, sold under the brand name "Robitussin Honey CF Max Day Adult" in 4-ounce and 8-ounce doses, along with its 8-ounce night-time version.
Failure of a dental implant is often related to the failure of the implant to osseointegrate correctly with the bone, or vice versa. [4] A dental implant is considered to be a failure if it is lost, mobile or shows peri-implant (around the implant) bone loss of greater than 1.0 mm in the first year and greater than 0.2 mm a year after. [5]
Orthopedic implant example seen with X-ray. An orthopedic implant is a medical device manufactured to replace a missing joint or bone, or to support a damaged bone. [1] The medical implant is mainly fabricated using stainless steel and titanium alloys for strength and the plastic coating that is done on it acts as an artificial cartilage. [2]